The Senior Manager will be responsible for the overall oversight of clinical studies ensuring the quality and integrity of riskbased monitoring deliverables. This involves developing comprehensive QCO Plans in collaboration with Clinical Trial Managers (CTMs) to detail strategies for maintaining high standards in monitoring activities. The role encompasses supporting study risk assessments and defining RBQM study needs and strategies which include determining the frequency and requirements for onsite versus remote monitoring activities targeted SDV and SDR and fostering constructive collaboration with crossfunctional teams such as biometrics/data management eTMF and medical/safety monitoring.

Additionally the Senior Manager will contribute to process excellence by maintaining and continually improving standard operating procedures related to clinical monitoring RiskBased Quality Management and clinical trial oversight. This includes reviewing and collaborating on the development of study plans that define riskbased monitoring strategies and tasks necessary for overseeing critical study data and processes. The role requires presenting QCO roles and procedures to study teams and CROs training CROs on QCO expectations and overseeing and evaluating monitoring deliverables such as Monitor Visit Reports CTMS data essential documents and critical system reports.

The Senior Manager will actively participate in study team teleconferences with CRO/vendors conduct site visits present findings serve as the point of contact for CROs regarding QCO activities and provide guidance on issue resolution. Consultation with CTMs and CROs to create action plans based on QCO findings to improve monitoring quality is also a key responsibility. Furthermore the role includes overseeing CRAs monitoring activities and performing management tasks such as MVR reviews accompanied visits and CRA teleconferences.

Close collaboration with crossfunctional study team members and critical business partners is essential to implement daytoday oversight activities while serving as a subject matter expert. The Senior Manager will perform gap assessments for internal and external SOPs/processes identify areas for process improvement in line with current guidance and global regulations leverage lessons learned to enhance procedures and develop related tools templates and training materials. Leading training activities for QCO representatives CRAs and crossfunctional study team members is also part of the job scope.

Performance Responsibilities

• Review and collaborate to develop fitforpurpose study plans that define riskbased monitoring strategies and the related tasks necessary to oversee critical study data and process (e.g. clinical monitoring plan centralized monitoring plan protocol deviation management plan and integrated quality risk management plan).
• Present QCO role and procedures to study team and CRO and train the CRO on the expectations for QCO activities.
• Oversee and evaluate monitoring deliverables/outputs including review of Monitor Visit Reports and related CTMS data eTMF/ISF essential documents data capture (e.g. EDC eCOA) and related queries critical system reports or analytics (e.g. central monitoring dashboards).
• Participate in study team teleconferences with CRO/vendors as necessary conduct site visits present findings from QCO visits and monitoring report reviews.
• Serve as the point of contact for CRO for QCO activities and provide guidance on issue resolution. Consult with CTM and CRO to create action plans based on QCO findings to improve monitoring quality.
• CRA Oversight: May perform management of CRAs and oversee monitoring activities including MVR review accompanied visits and CRA teleconferences.
• Close collaboration with cross functional study team members and critical business partners (e.g. CROs) to implement daytoday oversight activities and serve as a subject matter expert.
• Perform gap assessments for internal and external (e.g. CRO) SOP/processes. Identify areas for process improvement in consideration of current guidances (e.g. ICH GCP) and global regulations (e.g. FDA EMA MHRA PMDA). Effectively leverage lessons learned to elucidate areas for process improvement. Develop related tools templates and training materials/work aids.
• Lead training activities for QCO representatives CRAs and/or members of cross functional study team.
• Support process improvement initiatives related to risk based and quantitative methods of sponsor trial oversight which improve the quality of monitoring output/data with a focus on analytics/metrics and automated workflows that leverage systems such as CTMS (e.g. Veeva Vault).
• With a focus on patient safety and data quality collaborate with study teams to define meaningful metrics with thresholds/limits (e.g. QTLs KRIs KPIs). Support study teams to develop and build data visualization (analytical) tools.
• Other duties as assigned.

Minimum Job Requirements

• Bachelors degree in a relevant field. At least 8 years minimum experience in clinical research monitoring preferably including knowledge of infectious disease and other therapeutic areas of relevance to assigned projects.
• A minimum of 5 years clinical trial experience within a pharmaceutical biotechnology or CRO required in a role leading others (e.g. managing other CRAs or leading a project team)
• Strong knowledge of GCP regulations (e.g. US EU JP) and pertinent U.S. FDA Code of Federal Regulations. Broader GXP knowledge is a plus.
• Familiarity with riskbased monitoring strategies and tools (e.g. KRIs QTLs central monitoring)
• Strong working knowledge of clinical systems: CTMS (e.g. Veeva Vault) EDC eTMF eCOA and data visualization dashboards
• Proficient at reviewing and interpreting clinical monitoring reports study data and trends for quality oversight
• Demonstrated analytical thinking attention to detail and ability to manage multiple priorities
• Strong written and verbal communication skills with the ability to present to internal teams CROs and external stakeholders

Competencies

• Proficiency in applying RBM principles (e.g. QTLs KRIs KPIs SDR SDV) and collaborating to define appropriate monitoring strategies for clinical studies.
• Strong knowledge of ICH GCP FDA EMA MHRA and PMDA regulations. Capable of identifying compliance gaps performing root cause analyses and driving corrective actions.
• Ability to oversee CRO performance review deliverables participate in teleconferences and guide resolution of issues especially around monitoring quality.
• Comfortable interpreting CTMS data central monitoring dashboards and other study analytics to identify trends risks and quality issues.
• Experience with specific industry technology and systems (e.g. Veeva Vault suite CTMS Medidata RAVE SharePoint data visualization tools such as Spotfire Tableau or other custom solutions).
• Navigates change with ease adapts quickly to new tools processes or regulations and supports others through transition.
• Conveys complex monitoring quality and datarelated information in a way that is easy to understand for both technical and nontechnical audiences. Adapts messaging to the audience.
• Demonstrates sensitivity and adaptability to cultural differences in communication work styles and expectations. Fosters inclusive collaboration across diverse teams and geographies.

Other Requirements

This position has significant managerial and decisionmaking authority.

Ability and willingness to travel up to 30 of the year both domestically and internationally

Additional Information

The base salary range for this fulltime position is $140000$165000. Individual pay is determined by several factors which include but are not limited to: jobrelated skills experience and relevant education or training. The range does not include the comprehensive benefits vehicle allowance bonus longterm incentive or any additional compensation that may be associated with this role.

Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race color religion sex (including pregnancy) sexual orientation gender identity marital status national origin age ancestry citizenship disability genetic information status as a disabled veteran a recently separated veteran Active Duty Wartime or Campaign Badge Veterans and Armed Forces Service Medal Veterans or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal state and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are in fact nondiscriminatory.

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